Global Regulatory CMC Manager

Global Regulatory CMC Manager – Katalyst CRO

Irvine, CA | $96,100 – $145,310

• Develop the CMC regulatory strategy for small molecules, including briefing packages, IND/CTA, NDA, and MAA filings.
• Prepare and review CMC submission documents, registration dossiers, and health authority responses with minimal supervision.
• Evaluate global regulatory change controls for CMC with supervision.
• Manage CMC activities related to developmental or commercial compounds with supervision.
• Represent Regulatory CMC on cross‑functional development/commercial teams and Regulatory Affairs teams.
• Participate in global regulatory interactions with health authorities with supervision.
• Facilitate document review meetings and discussions.
• Maintain knowledge of the regulatory environment, regulations, and procedures.

• BS/BA in a Scientific Discipline (master's or higher preferred).
• 5+ years in the pharmaceutical industry, with 2+ years CMC regulatory experience.
• Experience with CMC regulatory documents (IND/CTAs, NDAs, MAAs, responses, variations, and briefing documents).
• Knowledge of FDA, EMA, and/or ICH guidelines and CMC regulations.
• Experience in drug development processes and post‑approval requirements.
• Experience developing CMC regulatory strategy.
• Experience in project management.
• Solution‑oriented approach to problem solving.
• Ability to plan/prioritize work of group members and guide/develop others.
• Ability to work on complex projects and within cross‑functional teams with supervision.
• Excellent communication skills, both written and oral.